Home NDC 0069-2465 Abrysvo
Product NDC 0069-2465
11-digit product format 000692465
Labeler code 0069
Product ID 0069-2465_22c6b04d-858c-4a16-9593-5643aabb0da9
Type VACCINE
Nonproprietary name Respiratory Syncytial Virus Vaccine
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR
Labeler Pfizer Laboratories Div Pfizer Inc
Application BLA125769
Marketing category BLA
Marketing start 2024-07-30
Substance RECOMBINANT STABILIZED RSV A PREFUSION F ANTIGEN; RECOMBINANT STABILIZED RSV B PREFUSION F ANTIGEN
Active strength .06; .06 mg/.5mL; mg/.5mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Abrysvo
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RECOMBINANT STABILIZED RSV A PREFUSION F ANTIGEN .06 mg/.5mL RECOMBINANT STABILIZED RSV B PREFUSION F ANTIGEN .06 mg/.5mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0069-2465-01 Abrysvo 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 14 0069-2465-10 Abrysvo 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 14 0069-2465-19 Abrysvo 0.5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 0.5 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0069-2465 ABRYSVO (RESPIRATORY SYNCYTIAL VIRUS VACCINE) KIT ABRYSVO (RESPIRATORY SYNCYTIAL VIRUS VACCINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 11 Current NDC, 3 package rows 20250112_be18292e-b1a2-4815-a0ed-003efaa6bea3.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125769 Abrysvo Respiratory Syncytial Virus Vaccine 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2642148 ABRYSVO 60 MCG / 60 MCG in 0.5 ML Injection PSN be18292e-b1a2-4815-a0ed-003efaa6bea3 14 2642142 respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 60 MCG / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 60 MCG in 0.5 ML Injection PSN be18292e-b1a2-4815-a0ed-003efaa6bea3 14 2642148 0.5 ML respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 0.12 MG/ML / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 0.12 MG/ML Injection [Abrysvo] SBD be18292e-b1a2-4815-a0ed-003efaa6bea3 14 2642142 0.5 ML respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 0.12 MG/ML / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 0.12 MG/ML Injection SCD be18292e-b1a2-4815-a0ed-003efaa6bea3 14 2642148 Abrysvo 60 MCG / 60 MCG per 0.5 ML Injection SY be18292e-b1a2-4815-a0ed-003efaa6bea3 14 2642142 respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 60 MCG / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 60 MCG per 0.5 ML Injection SY be18292e-b1a2-4815-a0ed-003efaa6bea3 14
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0069-2465-01 00069246501 1 VIAL in 1 CARTON (0069-2465-01) / .5 mL in 1 VIAL (0069-2465-19) 1 vial 2024-07-30 No No Current 0069-2465-10 00069246510 10 VIAL in 1 CARTON (0069-2465-10) / .5 mL in 1 VIAL (0069-2465-19) 10 vial 2024-07-30 No No Current 0069-2465-19 00069246519 0.5 mL in 1 VIAL 0.5 ml Historical